Telesupport: Evaluation of Professionally Led Support Groups for Caregivers

Caregiver Burden Clinical Trial

Official title:

Evaluation of Professionally Led Support Groups for Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259415
• Other study ID #: IIRG-00-1998
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2005
• Last updated: July 6, 2015
• Start date: September 2000

Study information

• Verified date: July 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Caregivers will be recruited for study participation who fit the following criteria:

1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.

Exclusion Criteria:

• Male

• under age of 55

• not a caregiver of person with ADRD

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Caregiver Burden

Intervention

Behavioral:
• Caregiver support via telephone

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver depression
Primary	Caregiver burdern
Primary	Caregiver social support